FDA Approves Nerlynx to Help Prevent HER2+ Breast CA Return

Share this content:
FDA Approves Nerlynx to Help Prevent HER2+ Breast CA Return
FDA Approves Nerlynx to Help Prevent HER2+ Breast CA Return

TUESDAY, July 18, 2017 (HealthDay News) -- Nerlynx (neratinib) has been approved by the U.S. Food and Drug Administration to help prevent human epidermal growth factor receptor type 2 (HER2)-positive breast cancer from returning.

Nerlynx, a kinase inhibitor that works by blocking several enzymes that promote cell growth, was evaluated in clinical studies involving 2,840 patients with early-stage HER2-positive breast cancer who had completed treatment with trastuzumab. After two years, 94.2 percent of users hadn't had their cancer recur, compared with 91.9 percent of those assigned to placebo.

The most common side effects of Nerlynx included diarrhea, nausea, abdominal pain, fatigue, vomiting, rash, and stomatitis. Patients who take the drug should be given the anti-diarrhea medication loperamide for the first 50 days of use, the FDA advised. Women who are pregnant shouldn't take Nerlynx because it can harm a developing fetus, the agency added.

"HER2-positive breast cancers are aggressive tumors and can spread to other parts of the body, making adjuvant therapy an important part of the treatment plan," Richard Pazdur, M.D., director of the FDA's Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research, said in a statement. "Now, these patients have an option after initial treatment that may help keep the cancer from coming back."

Approval for Nerlynx was granted to Puma Biotechnology, based in Los Angeles.

More Information

Share this content:

is free, fast, and customized just for you!

Already a member?

Sign In Now »


Sign up for myCME e-newsletters


Drug Lookup

Browse drugs by: BrandGenericDisease

Trending Activities

All Professions

More in Home

Zika Does Not Appear to Last in Semen As Long As Thought

Zika Does Not Appear to Last in Semen ...

More research is needed to better inform public health recommendations

Radioiodine Therapy for Thyroid Cancer Doesn't Up Stroke Risk

Radioiodine Therapy for Thyroid Cancer Doesn't Up Stroke ...

I-131 therapy group showed no significantly higher risk of ischemic or hemorrhagic stroke

Higher Odds of Infection With Reduced Kidney Function

Higher Odds of Infection With Reduced Kidney Function

Study finds excess community-acquired infections incidence in individuals with mild to severe CKD

is free, fast, and customized just for you!

Already a member?

Sign In Now »